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NCT02097134 · OUTCOME

Probability of Ocular Salvage

Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma · Source last updated 2023-10-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
2 years

What was measured

A patient will be considered an ocular-salvage success if enucleation because of disease progression or toxicity is not required during the 2 years following enrollment.

Analysis population: One patient who did not receive protocol therapy was excluded. Two patients who were lost to follow-up or follow-up was terminated electively prior to 2 years by patient or parent preference were excluded.

Groups in this outcome

Melphalan

Patients will receive 1 intra-arterial injection (IA) of melphalan every 21- 30 days. Injections may be repeated every 21-30 days (up to a maximum of 3 cycles) assuming the patients meets the criteria to begin the next cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Melphalan11

Reported measurements

Source class 1
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Melphalan36Not reported1565Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15
        upper Limit
        65
        value
        36
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
A patient will be considered an ocular-salvage success if enucleation because of disease progression or toxicity is not required during the 2 years following enrollment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients will receive 1 intra-arterial injection (IA) of melphalan every 21- 30 days. Injections may be repeated every 21-30 days (up to a maximum of 3 cycles) assuming the patients meets the criteria to begin the next cycle.
    id
    OG000
    title
    Melphalan
param Type
NUMBER
population Description
One patient who did not receive protocol therapy was excluded. Two patients who were lost to follow-up or follow-up was terminated electively prior to 2 years by patient or parent preference were excluded.
reporting Status
POSTED
time Frame
2 years
title
Probability of Ocular Salvage
type
SECONDARY
unit Of Measure
Percentage of patients

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice